Sanofi shows off positive PhIII trial results for Toujeo, opening the door to a new group of diabetes patients
A little under two months since their latest setback in diabetes R&D as their dominant perch in the market is shaken by severe headwinds, Sanofi had some positive results to report Monday from a Phase III trial applying its Lantus insulin followup in childhood and adolescent type 1 diabetes.
Comparing 223 patients given Toujeo (insulin glargine 300 units/mL) for 26 weeks against a control arm given the baseline Lantus treatment (insulin glargine 100 units/mL), Sanofi found comparable rates of several types of hypoglycemic events. The patients were aged 6 to 17. The results earned Sanofi a CHMP positive opinion for expanding Toujeo to T1 diabetes patients.
Once the king of one of pharma’s oldest kingdoms, the French drugmaker has seen its position fall off substantially in the past few years as competitors unveiled biosimilars and new forms of treatment, including GLP-1 agonists and SGLT1/2 inhibitors. A $7 billion per year drug as recently as 2015, Lantus, Sanofi’s basal insulin, earned $2.28 billion this year as of last week’s q3 results – on pace for about $3 billion in 2019. That’s over a 50% slide in less than 5 years.
Toujeo was intended as Sanofi’s followup to Lantus, but thus far has only been approved in adults and has failed to pick up the slack. It brought in $649 million as of Q3. Overall their diabetes franchise fell by 7.5% and their glargine drugs by 13.5%.
Comparing Toujeo to Lantus in children and adolescents, Sanofi found non-inferiority, with the newer drug performing slightly better on all markers. In both groups, roughly 97% had a severe or documented hypoglycemic incident of ≤ 70 mg/dL. In the Toujeo group, 80.3% had a severe or documented hypoglycemic event of < 54 mg/dL, compared with 83.8% of the Lantus group.
Eyeing a more targeted future for diabetes treatment, Sanofi bet big on Lexicon Pharmaceuticals in 2015. They agreed to pay $300 million and up to $1.7 billion long-term for their SGLT inhibitors.
That future came: Last year, Boehringer Ingelheim grabbed $1.75 billion for its SGLT-2 inhibitor and Eli Lilly earned $3.2 billion for their once-weekly GLP-1 agonist Trulicity, a form of treatment Novo Nordisk just developed a pill for. But Sanofi has been left out of it. Following an FDA rejection, the drugmaker spent $260 million to break off the deal, and now their official R&D report lists only 2 diabetes projects out of 85 clinical-stage programs – Efpeglenatide for type 2 diabetes and SAR341402, a biosimilar to Novo Nordisk’s NovoLog (insulin aspart).